Editor’s note: This is the second in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.

In part one of this series, I discussed the management perception that current good manufacturing practices (cGMPs) are not relevant to the business. I laid out the defense that cGMPs enable a predictable quality outcome that serves the business and its customers (e.g., patients) very well. The quality function should be in the best position to make this defense, but all too often it has problems of its own.

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